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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
510(k) Number K993724
Device Name HSV-2 ELISA IGG, MODEL EL0920G
Applicant
Mrl Diagnostics
10703 Progress Way
Cypress,  CA  90630
Applicant Contact MICHAEL J WAGNER
Correspondent
Mrl Diagnostics
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact MICHAEL J WAGNER
Regulation Number866.3305
Classification Product Code
MYF  
Date Received11/03/1999
Decision Date 02/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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